ECSP21067816A - PHARMACEUTICAL FORMULATIONS - Google Patents

PHARMACEUTICAL FORMULATIONS

Info

Publication number
ECSP21067816A
ECSP21067816A ECSENADI202167816A ECDI202167816A ECSP21067816A EC SP21067816 A ECSP21067816 A EC SP21067816A EC SENADI202167816 A ECSENADI202167816 A EC SENADI202167816A EC DI202167816 A ECDI202167816 A EC DI202167816A EC SP21067816 A ECSP21067816 A EC SP21067816A
Authority
EC
Ecuador
Prior art keywords
pharmaceutical formulations
preparing
processes
treatment
polyethylene glycol
Prior art date
Application number
ECSENADI202167816A
Other languages
Spanish (es)
Inventor
Audrey Antoinette Renée Lathuile
Rene Holm
Kristof Leonard Kimpe
Hana Prokopcová
Thomas Eddy R Neefs
Sanket Manoj Shah
Original Assignee
Janssen Pharmaceutica Nv
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Janssen Pharmaceutica Nv filed Critical Janssen Pharmaceutica Nv
Publication of ECSP21067816A publication Critical patent/ECSP21067816A/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • A61K9/4825Proteins, e.g. gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/472Non-condensed isoquinolines, e.g. papaverine
    • A61K31/4725Non-condensed isoquinolines, e.g. papaverine containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4151,2-Diazoles
    • A61K31/41551,2-Diazoles non condensed and containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4833Encapsulating processes; Filling of capsules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La invención se refiere a formulaciones farmacéuticas que comprenden un principio farmacéutico activo, un polietilenglicol que tiene un punto de congelación de al menos aproximadamente 30 ºC y un inhibidor de la tasa de cristalización. También se describen formas farmacéuticas sólidas que comprenden dichas formulaciones farmacéuticas, procesos para prepararlas y su uso en métodos de tratamiento.The invention relates to pharmaceutical formulations comprising an active pharmaceutical ingredient, a polyethylene glycol having a freezing point of at least about 30°C, and a crystallization rate inhibitor. Solid dosage forms comprising said pharmaceutical formulations, processes for preparing them and their use in methods of treatment are also described.

ECSENADI202167816A 2019-02-22 2021-09-14 PHARMACEUTICAL FORMULATIONS ECSP21067816A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN2019075844 2019-02-22

Publications (1)

Publication Number Publication Date
ECSP21067816A true ECSP21067816A (en) 2021-12-30

Family

ID=69650609

Family Applications (1)

Application Number Title Priority Date Filing Date
ECSENADI202167816A ECSP21067816A (en) 2019-02-22 2021-09-14 PHARMACEUTICAL FORMULATIONS

Country Status (21)

Country Link
US (1) US20220175760A1 (en)
EP (1) EP3927324A1 (en)
JP (1) JP2022523371A (en)
KR (1) KR20210132099A (en)
CN (1) CN113473971B (en)
AU (1) AU2020225342A1 (en)
BR (1) BR112021016411A2 (en)
CA (1) CA3129356A1 (en)
CR (1) CR20210480A (en)
EA (1) EA202192322A1 (en)
EC (1) ECSP21067816A (en)
IL (1) IL285674A (en)
JO (1) JOP20210230A1 (en)
MA (1) MA55015A (en)
MX (1) MX2021010144A (en)
PE (1) PE20212323A1 (en)
PH (1) PH12021552020A1 (en)
SG (1) SG11202109102PA (en)
TW (1) TW202045159A (en)
UY (1) UY38593A (en)
WO (1) WO2020169738A1 (en)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI795381B (en) 2016-12-21 2023-03-11 比利時商健生藥品公司 Pyrazole derivatives as malt1 inhibitors
EP3953345B1 (en) 2019-04-11 2023-04-05 Janssen Pharmaceutica NV Pyridine rings containing derivatives as malt1 inhibitors
TW202227067A (en) 2020-08-21 2022-07-16 比利時商健生藥品公司 Amorphous form of a malt1 inhibitor and formulations thereof
JP2023538099A (en) * 2020-08-21 2023-09-06 ヤンセン ファーマシューティカ エヌ.ベー. A pharmaceutical formulation comprising a MALT1 inhibitor and a mixture of polyethylene glycol with a fatty acid
BR112023017689A2 (en) * 2021-03-03 2023-11-14 Janssen Pharmaceutica Nv METHOD OF TREATMENT OF A CONDITION WITH THE USE OF A THERAPEUTICLY EFFECTIVE DOSE OF THE MALT1 INHIBITOR JNJ-67856633 (1-(1-OXO-1,2-DIHYDROISOQUINOLIN-5-IL)-5-(TRIFLUOROMETHYL)-N( 2-(TRIFLUOROMETHYL)PYRIDIN-4-IL)-1H-PYRAZOLE-4-CARBOXAMIDE)
CN118451068A (en) * 2021-12-30 2024-08-06 上海翰森生物医药科技有限公司 Tri-fused ring derivative inhibitor, preparation method and application thereof
WO2025073968A1 (en) 2023-10-06 2025-04-10 Ionctura Sa Combination of roginolisib with a malt1-gls inhibitor

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6248363B1 (en) * 1999-11-23 2001-06-19 Lipocine, Inc. Solid carriers for improved delivery of active ingredients in pharmaceutical compositions
WO2006037348A1 (en) * 2004-10-01 2006-04-13 Lifecycle Pharma A/S Pharmaceutical compositions comprising fenofibrate and a statin
US9789187B2 (en) * 2009-02-11 2017-10-17 Cadila Pharmaceuticals Limited Stable pharmaceutical composition for atherosclerosis
WO2010118078A1 (en) * 2009-04-08 2010-10-14 Idenix Pharmaceuticals, Inc. Macrocyclic serine protease inhibitors
US8252821B2 (en) * 2009-04-14 2012-08-28 Bristol-Myers Squibb Company Bioavailable capsule compositions of amorphous alpha-(N-sulfonamido)acetamide compound
KR20210033067A (en) * 2012-06-04 2021-03-25 파마싸이클릭스 엘엘씨 Crystalline forms of a bruton's tyrosine kinase inhibitor
IL315294A (en) * 2015-03-03 2024-10-01 Pharmacyclics Llc Pharmaceutical formulations of proton tyrosine kinase inhibitor
CN107296807B (en) * 2016-04-15 2020-03-20 中国科学院上海生命科学研究院 Application of MALT1 targeted inhibitor in preparation of MALT 1-dependent tumor treatment drug
TWI795381B (en) * 2016-12-21 2023-03-11 比利時商健生藥品公司 Pyrazole derivatives as malt1 inhibitors

Also Published As

Publication number Publication date
MA55015A (en) 2021-12-29
CR20210480A (en) 2021-11-10
JP2022523371A (en) 2022-04-22
KR20210132099A (en) 2021-11-03
CN113473971B (en) 2024-07-02
EP3927324A1 (en) 2021-12-29
PH12021552020A1 (en) 2022-09-12
US20220175760A1 (en) 2022-06-09
WO2020169738A1 (en) 2020-08-27
AU2020225342A1 (en) 2021-08-19
TW202045159A (en) 2020-12-16
BR112021016411A2 (en) 2021-10-13
CA3129356A1 (en) 2020-08-27
PE20212323A1 (en) 2021-12-14
EA202192322A1 (en) 2021-12-03
JOP20210230A1 (en) 2023-01-30
SG11202109102PA (en) 2021-09-29
CN113473971A (en) 2021-10-01
MX2021010144A (en) 2021-09-14
IL285674A (en) 2021-10-31
UY38593A (en) 2020-08-31

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